Module 14: Design Development and Certification of Medical Devices

17/11/2023

CLINICAL EVALUATION REPORT

• Device Name and UDI • Description, inc. previous versions, differences, accessories and products intended to be used in combination with the device • Intended purpose, including the indication, contraindications and target population • Note any diagnostic or therapeutic alternatives that are available • Reference any harmonized standards or common specifications applied • Relevant information on post-market clinical follow-up • Any requirements or training needs for users • Information on any warnings or precautions for use, undesirable effects, or other risks.

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

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• Instructions for Use • Key information to ensure safe and correct use of the device • Wording must be simple and easy to understand • Use a design that is easy to read • Labelling on the device • Labelling of the container • Mock-ups of the labels/containers • Physician labelling / e-labelling / operators manuals • Other training materials Labelling and Promotional Material

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

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